Blues highlight medical, benefit policy changes

A9699

Basic Benefit and Medical Policy
Xofigo^® treatment is considered established when the FDA-approved indications are met. The FDA-approved Xofigo (radium Ra 223 dichloride) for symptomatic late-state (metastatic) castration-resistant prostate cancer that has reached bones but not other organs, i.e. with no known visceral metastatic disease. This policy is effective May 15, 2013.

Xofigo should be reported with not-otherwise-classified code A9699 until a permanent code is established.

The recommended dose and schedule for Xofigo is 50 kBq/kg (1.35 microcuries/kg) administered by slow intravenous injection over one minute every four weeks for six doses.

52287*

**May be billed with appropriate botulinum toxin procedure code J0585, J0586, J0587 or J0588

Basic Benefit and Medical Policy
The safety and effectiveness of FDA-approved formulations of botulinum toxin, e.g., Botox^® (onabotulinumtoxinA), Myobloc^® (rimabotulinumtoxinB), DysportTM (abobotulinumtoxinA) and Xeomin^® (incobotulinumtoxinA) have been established. They may be considered useful therapeutic options for patients who meet the appropriate selection criteria, which have been updated, effective July 1, 2013.

Payment Policy
Service subject to preauthorization where indicated.

Inclusionary Guidelines
Note: The approved indications for Botulinum toxin type A and Botulinum toxin type B differ. Indications for the two botulinum toxin products have been combined in this policy. It is the responsibility of providers, however, to use each drug in accordance with approved indications unless there are valid and documented reasons stating why the unapproved or unaccepted form is used. While this policy contains a single list of covered indications, this is not meant to imply that the two botulinum toxin products (types A and B) or different brands (e.g., Xeomin vs. Dysport) are interchangeable.

The use of botulinum toxin may be considered established for the following conditions (Note: ** indicates an FDA-approved indication for at least one of the agents):

• Cervical dystonia (spasmodic torticollis; applicable whether congenital, due to child birth injury or traumatic injury). For this use, cervical dystonia must be associated with sustained head tilt or abnormal posturing with limited range of motion in the neck and a history of recurrent involuntary contraction of one or more of the muscles of the neck, e.g., sternocleidomastoid, splenius, trapezius or posterior cervical muscles*. (See additional details in Policy Guidelines section.)
• Strabismus**
• Blepharospasm or facial nerve (VII) disorders (including hemifacial spasm)**
• Primary focal hyperhidrosis (palmar or axillary only) in patients who meet any of the following conditions:
• Acrocyanosis of the hands
• History of recurrent skin maceration with bacterial or fungal infections
• History of recurrent secondary infections
• History of persistent eczematous dermatitis in spite of medical treatments with topical dermatological or systemic anticholinergic agents.
• Upper limb spasticity**
• Dystonia or spasticity resulting in functional impairment (interference with joint function, mobility, communication, nutritional intake) or pain in patients with any of the following:
• Focal dystonias:
  • Focal upper limb dystonia (e.g., organic writer’s cramp)
  • Oromandibular dystonia (orofacial dyskinesia, Meige syndrome)
  • Laryngeal dystonia (adductor spasmodic dysphonia)
  • Idiopathic (primary or genetic) torsion dystonia
  • Symptomatic (acquired) torsion dystonia
• Spastic conditions (including, but not limited to)
• Cerebral palsy
• Spasticity related to stroke
• Acquired spinal cord or brain injury
• Hereditary spastic paraparesis
• Spastic hemiplegia
• Neuromyelitis optica
• Multiple sclerosis or Schilder’s disease
• Esophageal achalasia in patients who have not responded to dilation therapy or who are considered poor surgical candidates
• Sialorrhea (drooling) associated with Parkinson disease
• Chronic anal fissure
• Incontinence due to detrusor overreactivity (urge incontinence), either idiopathic or due to neurogenic causes (e.g., spinal cord injury, multiple sclerosis), that is inadequately controlled with anticholinergics**
• Overactive bladder that is nonresponsive to anticholinergics or for patients who cannot tolerate anticholinergics
• Prevention (treatment) of chronic migraine headache in the following situations.** On Oct. 16, 2010, the U.S. Food and Drug Administration approved onabotulinumtoxinA for headache prophylaxis in patients with adult chronic migraine who suffer headaches on 15 or more days per month, each lasting more than four hours. 
• Initial six-month trial: Adult patients who meet established diagnostic criteria for chronic migraine headache. Chronic migraine is defined as migraine attacks that meet the above criteria and occur on at least 15 days per month for at least three months, provided there is no medication overuse,and have symptoms that persist despite trials of at least two agents used to prevent migraines or reduce migraine frequency representing different classes of medications. (Note: Patients who have contraindications to preventive medications are not required to undergo a trial of these agents).Agents used for prevention of migraines or reduction in their frequency include:
• Cardiovascular drugs (beta-blockers such as Inderal^®)
• Antidepressants (tricyclics such as Pamelor^®, Vivactil^®, Elavil^®)
• Tricyclics (e.g., Pamelor^®, Vivactil^®)
• Selective serotonin reuptake inhibitors
• norepinephrine reuptake inhibitors (e.g., Effexor^®)
• Anti-seizure drugs (e.g., Depakote^®, Topamax^®, Neurontin^®)
• Cyproheptadine (an antihistamine)

• Continuing treatment beyond 6 months requires documentation that:
• Migraine headache frequency has been reduced by at least seven days per month from the time of initial presentation for migraine treatment.
• Migraine headache duration has been reduced by at least 100 hours per month from the initial presentation for migraine treatment.

Exclusionary Guidelines
With the exception of cosmetic indications, the use of botulinum toxin is considered experimental for all other indications not specifically mentioned above, including, but not limited to

• Benign prostatic hyperplasia
• Bruxism
• Chronic low back pain (including sciatica due to piriformis syndrome)
• Chronic motor tic disorder (ICD-9 307.22), and tics associated with Tourette syndrome (motor tics) (ICD-9 307.23)
• Chronic spinal pain (any location)
• Detrusor sphincteric dyssynergia (after spinal cord injury)
• Esophageal stricture secondary to radiation therapy
• Gastroparesis
• Headaches, except as noted above for prevention (treatment) of chronic migraine headache
• Hirschsprung’s disease
• Interstitial cystitis
• Joint pain
• Lateral epicondylitis
• Mechanical neck disorders
• Myofascial pain syndrome
• Neuropathic pain after neck dissection
• Pain after hemorrhoidectomy or lumpectomy
• Sialorrhea (drooling), except that associated with Parkinson disease
• Tinnitus
• Temporomandibular joint disorders or myofascial or facial pain due to TMJ disorders
• Tremors such as benign essential tremor (upper extremity)

The use of botulinum toxin may be considered not medically necessary (cosmetic) as a treatment of wrinkles or other cosmetic indications.

Group Variations
Criteria for Federal Employee Program^® members differ. Please check member benefits and eligibility on web-DENIS.

96000-96004

Basic Benefit and Medical Policy
The safety and effectiveness of comprehensive gait analysis have been established. It may be considered a useful diagnostic option in specified situations. The exclusions have been updated, effective Sept. 1, 2013.

Inclusionary Guidelines

• As an aid in surgical planning in patients with gait disorders associated with cerebral palsy

Exclusionary Guidelines

• Surgical planning for conditions other than gait disorders associated with cerebral palsy
• Postoperative evaluation of surgical outcomes and rehabilitation planning or evaluation for all conditions
• Gait analysis that is not comprehensive

J7303

Payment Policy
Effective Jan. 1, 2012, NuvaRing is payable every 28 days.

19296-19298, 77261-77263, 77280, 77285, 77290, 77295, 77326-77328, 77776-77778, 77785-77787, 0182T

Basic Medical and Medical Policy
The criteria for the accelerated breast irradiation after breast-conserving surgery for early stage breast cancer and breast brachytherapy as boost with whole-breast irradiation policy has been updated, effective Sept. 1, 2013. 

Inclusionary Guidelines
Following breast-conserving surgery for early stage breast cancer:

• Accelerated whole breast irradiation for patients who meet the following conditions:
• Invasive carcinoma of the breast. Exclude disease involving the margins of excision; tumors greater than 5 cm in diameter; breast width greater than 25 cm at posterior border of medial and lateral tangential beams.
• Negative lymph nodes
• Technically clear surgical margins
• Interstitial or balloon brachytherapy may be considered established for patients undergoing initial treatment for Stage I or II breast cancer when used as local boost irradiation in patients who are also treated with breast-conserving surgery and whole-breast external-beam radiotherapy.

Exclusionary Guidelines

• Accelerated whole breast irradiation for patients not meeting the above inclusions
• Accelerated partial breast irradiation, including interstitial APBI, balloon APBI, external beam APBI and intra-operative APBI
• Interstitial or balloon brachytherapy in all other situations not specified under the inclusions

Local boost irradiation when combined with whole-breast radiotherapy but without surgical excision. There is a lack of published data to validate the efficacy of brachytherapy without surgical excision of the tumor.

Basic Benefit and Medical Policy
The criteria for the Pancreas Transplant policy have been updated. This policy is effective Sept. 1, 2013.

Inclusionary and Exclusionary Guidelines
The following pancreas transplants are considered to be established procedures:

• A combined pancreas-kidney transplant (SPK) for insulin-dependent diabetic patients with uremia
• Pancreas transplant after a prior kidney transplant (PAK) for patients with insulin dependent diabetes
• Pancreas transplant alone may be for patients with severely disabling and potentially life-threatening complications due to hypoglycemia unawareness and labile insulin dependent diabetes that persists in spite of optimal medical management.
• Pancreas retransplant after a failed primary pancreas transplant

Contraindications
Absolute and relative contraindications represent situations where proceeding with transplant may not be advisable in the context of limited organ or tissue availability. Contraindications may evolve over time as transplant experience grows in the medical community. Clinical documentation supplied to the health plan must demonstrate that attending staff at the transplant center have considered all contraindications as part of their overall evaluation of potential organ transplant recipients and have decided to proceed.

Relative contraindications
The selection process for approved tissue transplants is designed to obtain the best result for each patient. Therefore, relative contraindications to HSCT may include, but are not limited to:

• Poor cardiac function: Ejection fraction should be greater than 45 percent with no overt symptoms of congestive heart failure.
• Poor pulmonary function: Pulmonary function tests must be greater than or equal to 50 percent of predicted value.
• Poor renal function: Renal creatinine clearance should be greater than 40 ml/min or creatinine must be less than or equal to 2mg/dl (unless an SPK is being done).
• Poor liver function: There should be no history of severe chronic liver disease.
• Presence of HIV or an active form of hepatitis B, hepatitis C or human T-cell lymphotropic virus (HTLV-1).

Absolute contraindications
Note: Potential contraindications are subject to the judgment of the transplant center:

• Known current malignancy, including metastatic cancer
• Recent malignancy with high risk of recurrence
• Untreated systemic infection making immunosuppression unsafe, including chronic infection
• Other irreversible end-stage disease not attributed to kidney disease
• History of cancer with a moderate risk of recurrence
• Systemic disease that could be exacerbated by immunosuppression
• Psychosocial conditions or chemical dependency affecting ability to adhere to therapy

Pancreas Specific Guidelines
Candidates for pancreas transplant alone should additionally meet one of the following severity of illness criteria:

• Documentation of severe hypoglycemia unawareness as evidenced by chart notes or emergency room visits
• Documentation of potentially life-threatening labile diabetes as evidenced by chart notes or hospitalization for diabetic ketoacidosis
• In addition, the vast majority of pancreas transplant patients will have Type 1 diabetes mellitus. Those transplant candidates with Type 2 diabetes mellitus, in addition to being insulin-dependent, should also not be obese (body mass index should be 32 or less). According to International Registry data, in 2010, 7 percent of pancreas transplant recipients had Type 2 diabetes.

Multiple Transplants
Although there are no standard guidelines regarding multiple pancreas transplants, the following information may aid in case review:

• If there is early graft loss resulting from technical factors (e.g., venous thrombosis), a retransplant may generally be performed without substantial additional risk.

Long-term graft losses may result from chronic rejection, which is associated with increased risk of infection following long-term immunosuppression, and sensitization, which increases the difficulty of finding a negative cross-match. Some transplant centers may wait to allow reconstitution of the immune system before initiating retransplant with an augmented immunosuppression protocol.

91110, 91111, 91299

Basic Benefit and Medical Policy
The criteria for the Wireless Capsule Endoscopy as a Diagnostic Technique in Disorders of the Small Bowel, Esophagus and Colon policy have been updated. This policy is effective Sept. 1, 2013.

Inclusionary Guidelines

• Initial diagnosis in patients with suspected Crohn’s disease without evidence of disease on conventional diagnostic tests such as small-bowel follow-through and upper and lower endoscopy
• Obscure gastrointestinal bleeding suspected of being of small bowel origin, as evidenced by prior inconclusive upper and lower gastrointestinal endoscopic studies
• For surveillance of the small bowel in patients with hereditary GI polyposis syndromes, including familial adenomatous polyposis and Peutz-Jeghers syndrome

Exclusionary Guidelines

• Use of wireless capsule for routine colorectal cancer screening, confirmation of lesions or pathology normally within the reach of upper or lower endoscopes
• Evaluation for the extent of involvement or management of known Crohn’s disease
• Known or suspected gastrointestinal obstruction, strictures or fistulas
• Evaluation of the esophagus, in patients with gastroesophageal reflux or other esophageal pathologies
• Evaluation of other gastrointestinal diseases not presenting with GI bleeding including, but not limited to, celiac sprue, irritable bowel syndrome or small bowel neoplasm
• Evaluation of the colon, including but not limited to, detection of colonic polyps or colon cancer

The patency capsule, when used to evaluate patency of the gastrointestinal tract before wireless capsule endoscopy

G0237, G0239, G0424, S9473

Basic Benefit and Medical Policy
The inclusionary and exclusionary guidelines have been updated for the Pulmonary Rehabilitation policy. This policy is effective Sept. 1, 2013.

Inclusionary Guidelines
Pulmonary rehabilitation may be appropriate:

• Following lung transplant
• For patients with disabling respiratory diseases who remain symptomatic despite optimal medical management as evidenced by all of the following:
• Be physically able, motivated and willing to participate in a pulmonary rehabilitation program
• Have documentation of smoking cessation or be enrolled in a smoking cessation program
• Diagnosis of a chronic but stable, respiratory system impairment that is under medical management
• Pulmonary function tests revealing forced vital capacity, forced expiratory volume in one second (FEV1), or diffusing capacity of the lungs for carbon monoxide (DLCO) (uncorrected for volume) less than 65 percent of predicted normal within one year prior to initiating pulmonary rehabilitation
• Exhibit disabling symptoms that significantly impair the patient’s level of functioning
• Expectation of measurable improvement in a reasonable and predictable time frame

The program must have active medical supervision that includes, at a minimum, a registered nurse providing direct supervision and a physician available on-site. The outpatient program generally includes team assessment, patient training, psychosocial intervention, supervised exercise and follow-up. Participation in pulmonary rehabilitation generally occurs for a period of four to six hours per week for eight to 12 weeks.

Candidates for pulmonary rehabilitation should be medically stable and not limited by another serious or unstable medical condition. Contraindications to pulmonary rehabilitation may include:

• Ischemic cardiac disease
• Acute cor pulmonale
• Severe pulmonary hypertension
• Significant hepatic dysfunction
• Metastatic cancer
• Renal failure
• Severe cognitive deficit
• Psychiatric disease that interferes with memory and compliance
• Substance abuse
• Disabling stroke

Exclusionary Guidelines

• Multiple courses of pulmonary rehabilitation, either as maintenance therapy in patients who initially respond or in patients who fail to respond or whose response to an initial rehabilitation program has diminished over time.
• Home-based pulmonary rehabilitation programs

0281T

Basic Benefit and Medical Policy
The use of percutaneous left-atrial appendage closure devices for the prevention of stroke in atrial fibrillation is considered experimental. This policy is effective Sept. 1, 2013.

0312T-0317T

Basic Benefit and Medical Policy
Vagal nerve blocking for the treatment of morbid obesity is experimental, effective Sept. 1, 2013. There is insufficient documentation in medical literature to indicate that the use of this device results in improved patient clinical outcomes.

Michigan Catholic Conference – Detroit

Effective Sept. 1, 2013, Medicare-eligible retirees of the Michigan Catholic Conference – Detroit, will have Blue Cross Blue Shield of Michigan’s Medicare Advantage PPO plan, Medicare Plus Blue Group PPO^SM, for their medical, surgical and prescription drug benefits. The group number is 60272 with suffix 600. You can identify members by the XYL prefix on their ID cards, like those of other Medicare Plus Blue Group PPO plans.

For information about our Medicare Advantage PPO plan, go to bcbsm.com/provider/ma.